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Aug 17, 2009

FDA Sanctions Novartis’ MS Drug

  • FDA approved Novartis’ Extavia®, a branded version of the multiple sclerosis drug, interferon beta-1b. FDA sanctioned the drug for the treatment of relapsing forms of MS, and for patients who have experienced a first clinical episode of MS and have MRI-consistent features of the disease.

    Novartis says that it plans to start making the drug available this autumn. Extavia is already marketed in 12 EU countries and was first launched in Germany and Denmark in January. European approval covers use of the drug for treating relapsing-remitting MS, secondary progressive MS with relapses, and early MS (a single demyelinating event with an active inflammatory process).

    Extavia will compete with Bayer Schering Pharma’s Betaseron®/Betaferon® branded interferon beta-1b. In 2007 Bayer Schering Pharma acquired Novartis’ U.S. biologics manufacturing facility in Emeryville, CA, which manufactured Betaseron. Novartis received some €137 million for the acquisition, which included the production facility, the transfer of related equipment and inventories, and the leasing of certain buildings.

    In return Bayer has supported Novartis in the regulatory filing of Extavia. The deal also provided for Bayer Schering Pharma to supply Extavia to Novartis from 2009 onward in return for a double-digit royalty payment. 

    Extavia is Novartis’ first MS drug to be cleared for marketing. The company’s MS pipeline includes the once-daily oral treatment, FTY720, which Novartis suggests could be submitted for approval during 2009.


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